(198 days)
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No
The summary describes a standard perinatal monitor using non-invasive sensors and graphical display/printing, with no mention of AI, ML, or related concepts.
No
The device is used for monitoring and assessment, not for direct treatment or therapy.
Yes
Explanation: The device measures and displays maternal abdominal contractions and fetal heart rate to "aid in assessing the well being of the fetus," which is a diagnostic purpose to evaluate the health status of the fetus.
No
The device description explicitly mentions hardware components like a "non-permanent graphical display" and a "thermal strip chart printer," indicating it is not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The VersaLab APM is described as a "Perinatal Monitoring system for non-invasively measuring and graphically showing both maternal abdominal contractions and the fetal heart rate". This involves external monitoring of physiological signals, not the analysis of samples taken from the body.
- Intended Use: The intended use is to "aid in assessing the well being of the fetus during the final trimester of pregnancy [Non-Stress Test]". This is a clinical assessment based on real-time physiological data, not laboratory analysis of a sample.
Therefore, the VersaLab APM falls under the category of a medical device used for physiological monitoring, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The VersaLab APM, antepartum monitor is a Perinatal Monitoring system for non-invasively measuring and graphically showing both maternal abdominal contractions and the fetal heart rate by means of display on a non-permanent graphical display as well as a permanent record on a thermal strip chart printer. This data is intended to aid in assessing the well being of the fetus during the final trimester of pregnancy [Non-Stress Test].
This device is for use by trained medical personnel located in hospitals, clinics and doctor's offices.
The device is for non-invasive use only. The device is not to be used on or near non-intact skin. The device is not to be used on or near the eyes. The device is to be used by or on order of a physician.
Product codes
85 HGM
Device Description
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Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
Trained medical personnel located in hospitals, clinics and doctor's offices.
Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
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Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
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Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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§ 884.2740 Perinatal monitoring system and accessories.
(a)
Identification. A perinatal monitoring system is a device used to show graphically the relationship between maternal labor and the fetal heart rate by means of combining and coordinating uterine contraction and fetal heart monitors with appropriate displays of the well-being of the fetus during pregnancy, labor, and delivery. This generic type of device may include any of the devices subject to §§ 884.2600, 884.2640, 884.2660, 884.2675, 884.2700, and 884.2720. This generic type of device may include the following accessories: Central monitoring system and remote repeaters, signal analysis and display equipment, patient and equipment supports, and component parts.(b)
Classification. Class II (performance standards).
0
Image /page/0/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an image of a stylized eagle with three lines representing the feathers. The eagle is facing to the right.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
APR 1 8 2002
Re: K013281
Trade/Device Name: VersaLab APM Regulation Number: 21 CFR 884.2740 Regulation Name: Perinatal monitoring system and accessories
Regulatory Class: II Product Code: 85 HGM Dated: January 31, 2002 Received: February 4, 2002
Mr. David W. Wagner Director of Quality Assurance And Regulatory Affairs Nicolet Vascular 6355 Joyce Dr. GOLDEN CO 80403
Dear Mr. Wagner:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (sections 531-542 of the Act); 21 CFR 1000-1050.
1
This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at one of the following numbers, based on the regulation number at the top of this letter:
| 8xx.1xxx | (301) 594-4591 |
|---|---|
| 876.2xxx, 3xxx, 4xxx, 5xxx | (301) 594-4616 |
| 884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx | (301) 594-4616 |
| 892.2xxx, 3xxx, 4xxx, 5xxx | (301) 594-4654 |
| Other | (301) 594-4692 |
Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.
Sincerely yours,
Nancy C. Brogdon
Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Abbreviated 510(k)
Device Name: VersaLab APM
Indications for Use:
The VersaLab APM, antepartum monitor is a Perinatal Monitoring system for non-invasively measuring and graphically showing both maternal abdominal contractions and the fetal heart rate by means of display on a non-permanent graphical display as well as a permanent record on a thermal strip chart printer. This data is intended to aid in assessing the well being of the fetus during the final trimester of pregnancy [Non-Stress Test].
This device is for use by trained medical personnel located in hospitals, clinics and doctor's offices.
The device is for non-invasive use only. The device is not to be used on or near non-intact skin. The device is not to be used on or near the eyes. The device is to be used by or on order of a physician.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
David A. Ingram
(Division Sign-Off) Division of Reproductive, Abdominal and Radinlogical Devices 510(k) Number _
Prescription Use X (per 21 CFR 801.109)
OR
Over-the-Counter Use